Orthopedic DisorderImp&acte3DNCT05947630

3D-printing and Acces to Tele Rehabilitation

A study testing Ankle Foot Orthosis (AFO) and Knee Ankle Foot Orthosis (KAFO) in people with Orthopedic Disorder, run by Lieven De Maesschalck at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 years and older
Conditions the study is for: Orthopedic Disorder
What is being tested?: Ankle Foot Orthosis (AFO) and Knee Ankle Foot Orthosis (KAFO)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 4 sitesin 3 countries
Study dates: 15 May 2018to 15 Apr 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Pathology: foot stance abnormality
Both unilateral and bilateral orthoses are included
Pathology: genu varum

Who cannot join

Patient is already wearing a night splint
The patient cannot stand upright
The patient is pregnant

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

Togo2 sites

CRAO
Dapaong
CNAO
Lomé

Mali1 site

CNAOM
Bamako

Other trials in Mali

Niger1 site

Centre Hospitalier Universitaire de Niamey
Niamey

Other trials in Niger

About this study

Official title: IMPression 3D & ACcès à la Teléréadaptation / 3D-printen en Toegang Tot Telerevalidatie

This study will investigate whether 3D printing of orthoses (night splints and AFO/KAFO for walking, further named as dynamic AFO/KAFO) for the lower limbs can help to improve the limited accessibility to orthopaedic devices in developing countries. The 3D printed orthoses will be assessed for effectiveness, cost and feasibility. Measurement and manufacture of the orthoses is also supported remotely via video conferencing.

Read the detailed description

Specifically, the study is being conducted in 3 West African countries: Togo, Niger and Mali. A total of 4 orthopaedic centres are involved, whereby an equal number of patients are recruited everywhere.

There are 2 groups of patients, those who need a (knee) ankle-foot orthosis to move around (dynamic AFO/KAFO) and those who need a night splint to correct the ankle or knee position. All patients in the study will have a treatment route involving fitting a new traditional orthosis and a new 3D printed orthosis. The order of application of both treatments will be randomised in a crossover design. Patients will be measured at baseline after the first treatment period (3 weeks) and after the second treatment period (6 weeks). The primary outcome measures are different for both groups of patients: the walking speed when performing the 10-metre walk test in the patients wearing the dynamic AFO/KAFO, and the measured angle (of knee or ankle) in the patients wearing a night splint.

Conditions: Orthopedic Disorder
Being tested: Ankle Foot Orthosis (AFO), Knee Ankle Foot Orthosis (KAFO)
Keywords: lower limb
Medical subject headings: Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ankle Foot Orthosis (AFO)Device
3D treatment (AFO will be printed) versus traditional made AFO
Knee Ankle Foot Orthosis (KAFO)Device
3D treatment (KAFO will be printed) versus traditional made KAFO

Study groups in NCT05947630
Study group	Role	What they receive
AFO (ankle foot orthosis) dynamic and correctional	Experimental	Groep A with AFO (ankle foot orthosis) dynamic and correctional Receives: Device: Ankle Foot Orthosis (AFO)
AFO or KAFO (knee ankle foot orthosis) correctional	No intervention	Groep B with AFO or KAFO (knee ankle foot orthosis) and only correctional
KAFO dynamic and correctional	Experimental	Groep C with KAFO dynamic and correctional Receives: Device: Knee Ankle Foot Orthosis (KAFO)
KAFO correctional	No intervention	Groep D with KAFO only correctional

What is being measured

The primary outcome is the main question the study is designed to answer.

10 meter walk test
10 meter walk test
Measured: 5 weeks
knee angle test
Knee angle test
Measured: 5 weeks
Ankle angle test
Ankle angle test
Measured: 5 weeks

Secondary outcomes (2)

OPUS questionnnaire
OPUS questionnnaire (measure on 5 point Likertscale: Very easy, Easy, Slightly difficult, Very difficult and Cannot do this activity and this for 21 items.
Measured: 5 weeks
Range of motion
Range of motion
Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 201815 Apr 2019

First posted17 Jul 2023
Study start15 May 2018
Primary completion31 Oct 2018
Study completion15 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05947630
Sponsor's protocol ID: S65004
Acronym: Imp&acte3D
Status last verified: Jul 2023
First submitted: 7 Oct 2021
Last updated: 17 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Creylman V, Knippels I, Janssen P, Biesbrouck E, Lechler K, Peeraer L. Assessment of transfemoral amputees using a passive microprocessor-controlled knee versus an active powered microprocessor-controlled knee for level walking. Biomed Eng Online. 2016 Dec 19;15(Suppl 3):142. doi: 10.1186/s12938-016-0287-6.
PubMed 28105945

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Orthopedic Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IMPression 3D & ACcès à la Teléréadaptation / 3D-printen en Toegang Tot Telerevalidatie
ClinicalTrials.gov ID: NCT05947630
Acronym / sponsor ID: Imp&acte3D / S65004
Conditions: Orthopedic Disorder
Keywords: lower limb
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Lieven De MaesschalckUniversity, hospital or other
Collaborators: Handicap International
Study start: 15 May 2018 (actual)
Primary completion: 31 Oct 2018 (actual)
Study completion: 15 Apr 2019 (actual)
First posted: 17 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
AFO (ankle foot orthosis) dynamic and correctional	Experimental	Device: Ankle Foot Orthosis (AFO)Groep A with AFO (ankle foot orthosis) dynamic and correctional
AFO or KAFO (knee ankle foot orthosis) correctional	No intervention	–Groep B with AFO or KAFO (knee ankle foot orthosis) and only correctional
KAFO dynamic and correctional	Experimental	Device: Knee Ankle Foot Orthosis (KAFO)Groep C with KAFO dynamic and correctional
KAFO correctional	No intervention	–Groep D with KAFO only correctional

Who may qualify

Ages: 4 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Pathology: foot stance abnormality
Both unilateral and bilateral orthoses are included
Pathology: genu varum

Key exclusion criteria (3 listed)

Patient is already wearing a night splint
The patient cannot stand upright
The patient is pregnant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ankle Foot Orthosis (AFO)3D treatment (AFO will be printed) versus traditional made AFO	Device	AFO (ankle foot orthosis) dynamic and correctional
Knee Ankle Foot Orthosis (KAFO)3D treatment (KAFO will be printed) versus traditional made KAFO	Device	KAFO dynamic and correctional

Primary outcome

10 meter walk test
Time frame: 5 weeks
10 meter walk test
knee angle test
Time frame: 5 weeks
Knee angle test
Ankle angle test
Time frame: 5 weeks
Ankle angle test

2 secondary outcomes

OPUS questionnnaire
Time frame: 5 weeks
Range of motion
Time frame: 5 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
Background: PubMed 28105945Creylman V, Knippels I, Janssen P, Biesbrouck E, Lechler K, Peeraer L. Assessment of transfemoral amputees using a passive microprocessor-controlled knee versus an active powered microprocessor-controlled knee for level walking. Biomed Eng Online. 2016 Dec 19;15(Suppl 3):142. doi: 10.1186/s12938-016-0287-6.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ankle Foot Orthosis (AFO) and Knee Ankle Foot Orthosis (KAFO) in people with Orthopedic Disorder, run by Lieven De Maesschalck at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Togo, Mali, Niger. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

10 meter walk test (time frame: 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05947630, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.